Packaging & Labeling Supervisor
- Supervise clinical label design, generation, documentation and overall label production operations. Assist in the coordination and assignment of temporary staff to packaging and labeling operations.
- Accurate completion of appropriate documentation relative to the preparation, packaging, and shipping of clinical supplies in accordance with cGMPs and departmental SOPs. Able to review and approve the work of others for compliance with established procedures, policies, and regulations. Demonstrate a superior level of good judgment in the completion of GMP activities in Clinical Supplies SCP. Supervises clinical label design, generation, documentation and overall label production operations.
- Compliance with established procedures, policies, and regulations. Identifies any operational deviations and notifies the appropriate Management. Conducts investigations, assessment of options and implementation of solutions in order to maintain a fully compliant operation within Clinical Supplies SCP.
- Accurate completion of appropriate documentation relative to the preparation, packaging, and shipping of clinical supplies in accordance with cGMPs and departmental SOPs. Ability to review and approve the work of others for compliance with established procedures, policies, and regulations. Demonstrates a superior level of good judgment in the completion of GMP activities in the Clinical Supplies Scientific Core Platform.
- Comprehensive proficiency with the departmental computerized inventory system (NASCA) for all packaging and labeling activities. Proficiency with CODESOFT for clinical label design.
- Supports the implementation of improvements in quality, productivity, regulatory compliance, cost-effectiveness, and safety. Supports the development of and assists in the implementation of improvements to documentation, SOP’s, and policies, governing multiple areas, including other departments.
- Leads in the training of packaging staff on procedures, label production processes, equipment operations, and SOPs. Makes recommendations on hiring decisions and performance management to Clinical Supplies Scientific Core Platform management.
- Conducts the first review of batch records as appropriate. Leads and participates in the set-up of label production equipment and packaging.
- Assists in the identification and recommendation for process improvements for all aspects of clinical label processes and production.
- Proposes ideas suitable for potential IT improvements in labeling activities.
- Participates in the validation/qualification of labeling equipment.
- Consults with labels, equipment and component vendors, as needed regarding orders and technical issues.
- Interacts daily with Packaging Project Management staff regarding label design, generation, and production documentation.
- Makes routine or scheduling decisions/prioritization.
- Must be able to learn the Phenix System.
- Must be able to work 2nd shift if required.
- BA/BS degree with a minimum of three years of pharmaceutical experience. Experience should include at least three years in clinical supplies packaging and label production role or equivalent experience. The individual should have at least three years of supervisory experience with a proven track record of managing full-time and temporary employees.
- Must possess knowledge of Good Manufacturing Practices (GMPs) and/or standard procedures for a pharmaceutical packaging or manufacturing operation. Understanding of the development process and demonstrated experience in the clinical supplies area is required. Comprehensive knowledge of GMP facility, equipment, packaging, and shipment operations to support clinical trials.
- Incumbent must possess general computer literacy. Must have familiarity with clinical label generation and inventory software.
- Strong oral and written communication, interpersonal, and negotiation skills.
- Ability to work with a high degree of accuracy and attention to detail.
- Will act as a backup Packaging Supervisor as needed.
- Ability to adjust to changing timelines.
- Demonstrated experience supervising technical staff members.
- Must be able to follow complex written and verbal instructions.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
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